Coordinated Project Management from
CEBIS supports clinical trials with project management focused on clear study planning, milestone tracking, cross-functional coordination, issue management and sponsor communication.
Project management can be provided for an individual study or integrated with clinical operations, data, regulatory, safety, supply and quality services.
A Clear Plan for
Clinical trial delivery starts with understanding the protocol and translating its requirements into a practical operational plan.
The project-management approach should establish how study activities, responsibilities and timelines fit together before active execution begins.
Planning can include:
Study Scope
Define the operational requirements based on the protocol, phase, population and study design.
Responsibilities
Clarify the roles of CEBIS, the sponsor, participating sites and other study partners.
Milestones
Establish key study activities and expected timelines.
Functional Coordination
Identify the clinical, regulatory, data, safety, supply and quality functions needed for delivery.
Communication Plan
Define how progress, decisions, risks and actions will be communicated.
Keeping Study
Start-Up Management
Coordinate early study activities, dependencies and readiness requirements.
Site Activation
Track participating sites as they move through required start-up activities toward activation.
Active Study Management
Coordinate clinical activities, milestones, enrollment and ongoing project needs during study conduct.
Data & Functional Coordination
Keep clinical execution aligned with data management, safety, regulatory and other supporting functions.
Closeout Coordination
Manage final actions and dependencies as sites and the wider study move toward completion.
Managing Progress and Emerging Study Risks
Milestone Tracking
Follow key project activities against the agreed study plan.
Risk Identification
Identify operational issues that may affect study delivery.
Issue Management
Assign actions and coordinate follow-up through resolution.
Escalation
Bring significant risks or decisions to the appropriate stakeholders.
Change Coordination
Manage the operational impact of approved study changes across affected functions.
Focused Support or
Not every sponsor requires the same level of project-management support.
Standalone Project Management
CEBIS can support project leadership and coordination for a defined study while other functions remain with the sponsor or other partners.
Integrated Study Management
Project management can be combined with clinical operations, monitoring, data, regulatory, safety, supply and quality services.
Clear Communication
Sponsors need timely information to understand study progress and make decisions.
Project communication can be organized around:
- Study progress
- Upcoming milestones
- Site activity
- Enrollment status
- Operational risks
- Open issues and actions
- Required sponsor decisions
- Changes affecting the project plan
Need Project Management for a Clinical Study?
Tell us about your study phase, scope, countries, sites, timeline and functional needs. A member of the CEBIS team can discuss the appropriate project-management approach.